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Research In Viral Eradication of HIV Reservoirs (RIVER)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02336074
First Posted: January 12, 2015
Last Update Posted: March 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Medical Research Council
University of Oxford
University of Cambridge
Chelsea and Westminster NHS Foundation Trust
Royal Free Hospital NHS Foundation Trust
Brighton and Sussex University Hospitals NHS Trust
Guy's and St Thomas' NHS Foundation Trust
Central and North West London NHS Foundation Trust
Information provided by (Responsible Party):
Imperial College London
  Purpose

This study will be a two-arm prospective 1:1 randomised controlled trial comparing:

Arm A: cART preferably including raltegravir (combination ART cART - control) Arm B: cART preferably including raltegravir (cART) plus ChAdV63.HIVconsv (ChAd) prime and MVA.HIVconsv (MVA) boost vaccines; followed by a 28-day course of vorinostat (10 doses in total).

We hypothesise that this intervention in primary HIV infection will confer a significant reduction in the latent HIV reservoir when compared with cART alone.


Condition Intervention Phase
HIV Drug: Combination Antiretroviral Therapy (cART) Drug: Raltegravir Drug: Vorinostat Biological: ChAdV63.HIVconsv (ChAd) Biological: MVA.HIVconsv (MVA) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Research In Viral Eradication of HIV Reservoirs

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Total HIV DNA from CD4 T-cells [ Time Frame: Averaged across post-randomisation week 16 and 18 ]
    The average of two measures taken at post-randomisation week 16 and 18


Secondary Outcome Measures:
  • Clinical and laboratory adverse events [ Time Frame: 42 weeks ]
  • Further assessment of the HIV reservoir [ Time Frame: 42 weeks ]
    Further assessment of the HIV reservoir e.g. HIV integrated DNA; HIV cell associated RNA; plasma HIV RNA measured with an ultra-low copy assay i.e. with a threshold of <1 copy/ml and viral outgrowth assays.

  • Studies of immune function [ Time Frame: 42 weeks ]
    Studies of immune function including measuring the latently-infected resting memory T-cells and cytotoxic immune responses

  • Changes in plasma IL-6 (an inflammatory biomarker) [ Time Frame: 42 weeks ]
    Effectiveness of the treatment will be assessed by monitoring the levels of IL-6, an inflammatory biomarker

  • Changes in plasma hCRP (an inflammatory biomarker) [ Time Frame: 42 Weeks ]
    Effectiveness of the treatment will be assessed by monitoring the levels of hCRP, an inflammatory biomarker

  • Changes in plasma TNF-alpha (an inflammatory biomarker) [ Time Frame: 42 Weeks ]
    Effectiveness of the treatment will be assessed by monitoring the levels of TNF-alpha, an inflammatory biomarker


Enrollment: 59
Actual Study Start Date: November 27, 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A
Combination Antiretroviral Therapy (cART) preferably including raltegravir prescribed at week 0 for the duration of the study up to post-randomisation week 18 (42 weeks in total)
Drug: Combination Antiretroviral Therapy (cART)
Likely consisting of an Nucleoside reverse-transcriptase inhibitor (NRTI) backbone i.e. Truvada plus a ritonavir-boosted protease inhibitor (PI) e.g. Darunavir + ritonavir. Prescribed at week 0 for the duration of the study.
Drug: Raltegravir
All participants will be dispensed sufficient supplies of Raltegravir to ensure they have sufficient medication to last to the next study visit. Raltegravir is supplied in marketed pack with 30 tablets per bottle.
Other Name: Isentress
Experimental: Arm B
Combination Antiretroviral Therapy (cART) preferably including raltegravir prescribed at week 0 for the duration of the study up to post-randomisation week 18 (42 weeks in total) Plus ChAdV63.HIVconsv prime (post-randomisation week 00) and MVA.HIVconsv boost (post randomisation week 08 day 1) vaccines; followed by a 28-day course of vorinostat (10 doses in total).
Drug: Combination Antiretroviral Therapy (cART)
Likely consisting of an Nucleoside reverse-transcriptase inhibitor (NRTI) backbone i.e. Truvada plus a ritonavir-boosted protease inhibitor (PI) e.g. Darunavir + ritonavir. Prescribed at week 0 for the duration of the study.
Drug: Raltegravir
All participants will be dispensed sufficient supplies of Raltegravir to ensure they have sufficient medication to last to the next study visit. Raltegravir is supplied in marketed pack with 30 tablets per bottle.
Other Name: Isentress
Drug: Vorinostat

Vorinostat (suberoylanilide hydroxamic acid abbreviated to SAHA) inhibits the histone deacetylases HDAC1, HDAC2, HDAC3 (Class I) and HDAC6 (Class II).

Vorinostat is supplied as capsules containing 100mg vorinostat and the following inactive ingredients: microcrystalline cellulose, sodium croscarmellose and magnesium stearate.

Biological: ChAdV63.HIVconsv (ChAd)
Dosage: 5x1010vp .This dose is obtained by injecting 0.37ml of the vaccine at 1.35x1011vp/ml without dilution. This prime vaccination is administered intramuscularly (IM) into the deltoid muscle of the non-dominant arm at post-randomisation week 00.
Biological: MVA.HIVconsv (MVA)
Dosage: 2x108pfu Administration: This dose is obtained by injecting 0.23 ml of the vaccine IM at 8.6x108pfu/ml without dilution. This boost vaccination is administered intramuscularly (IM) into the deltoid muscle of the non-dominant arm at post-randomisation week 08 Day 1 (2 prior to start of vorinostat)

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Aged ≥18 to ≤60 years old
  2. Able to give informed written consent including consent to long-term follow-up
  3. Should be enrolled within a maximum of 4 weeks of a diagnosis of primary HIV-1 infection confirmed by one of the following criteria:

    1. Positive HIV-1 serology within a maximum of 12 weeks of a documented negative HIV-1 serology test result (can include point of care test (POCT) using blood for both tests)
    2. A positive p24 antigen result and a negative HIV antibody test
    3. Negative antibody test with either detectable HIV RNA or proviral DNA
    4. PHE RITA test algorithm (a) reported as "Incident" confirming the HIV-1 antibody avidity is consistent with recent infection (within the preceding 16 weeks).
    5. Weakly reactive or equivocal 4th generation HIV antibody antigen test
    6. Equivocal or reactive antibody test with <4 bands on western blot
  4. Adequate haemoglobin (Hb≥12g/dL for males, ≥11g/dL for females)
  5. Weight ≥50kg
  6. Willing to be treated with cART (preferably including raltegravir) and be randomised to continue cART alone or cART plus intervention (HIV vaccines plus HDACi)
  7. Willing and able to comply with visit schedule and provide blood sampling

Exclusion criteria

  1. Women of child bearing potential (WCBP) (b)
  2. In women with intact ovaries and no uterus, any planned egg donation anytime in the future to a surrogate
  3. Intention to donate sperm or father a child within 6 months of the intervention
  4. Co-infection with hepatitis B (surface antigen positive or detectable HBV DNA levels in blood) or hepatitis C (HCV RNA positive or HVC antigen positive)
  5. Any current or past history of malignancy
  6. Concurrent opportunistic infection or other comorbidity or comorbidity likely to occur during the trial e.g.past history of ischaemic or other significant heart disease, malabsorption syndromes, autoimmune disease
  7. Any contraindication to receipt of BHIVA recommended combination antiretrovirals
  8. HIV-2 infection
  9. Known HTLV-1 co-infection
  10. Prior immunisation with any experimental HIV Immunogens (including any component of the vaccines used in the RIVER protocol; simian or human adenoviral vaccine; other experimental HIV vaccines)
  11. Current or planned systemic immunosuppressive therapy (inhaled corticosteroids are allowed)
  12. Any history of proven thromboembolism (pulmonary embolism or deep vein thrombosis)
  13. Any inherited or acquired bleeding diathesis including gastric or duodenal ulcers, varices
  14. Concurrent or planned use of any drugs contraindicated with vorinostat i.e. antiarrhythmics; any other drugs that prolong QTc; warfarin, aspirin, sodium valproate
  15. Prior intolerance of any of either the components of the vaccine or HDACi,
  16. Uncontrolled diabetes mellitus defined as an HBA1C>7%
  17. Any congenital or acquired prolongation of the QTc interval, with normal defined as ≤0.44s (≤440ms)
  18. Participation in any other clinical trial of an experimental agent or any non-interventional study where additional blood draws are required; participation in an observational study is permitted
  19. Allergy to egg
  20. History of anaphylaxis or severe adverse reaction to vaccines
  21. Planned receipt of vaccines within 2 weeks of the first trial vaccination administered at PR week 00 (including vaccines such as yellow fever; hepatitis B, influenza)
  22. Abnormal blood test results at screening including:

    1. Moderate to severe hepatic impairment as defined by Child-Pugh classification
    2. ALT >5xULN
    3. Platelets <150x109/L
    4. eGFR <60 (c)
    5. uPCR >30 mg/mmol
  23. Physical and laboratory test findings: Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination and/or vital signs that the investigator believes is a preclusion from enrolment into the study
  24. Active alcohol or substance use that, in the Investigator's opinion, will prevent adequate adherence with study requirements
  25. Insufficient venous access that will allow scheduled blood draws as per protocol

    1. using current cut-offs for optical density as defined by PHE
    2. females aged <20 years of age, and weighing <65kg and <168cm in height will need to have an estimation of blood volume (EBV) prior to enrolment, >3500mL before to participate. This circumstance is unlikely to arise as most women between the ages of 18 to 20 years would be of child-bearing potential (CBP) and excluded on that basis.
    3. eGFR is calculated by the local labs using CKD-EPI. Units ml/min/1.73m2.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02336074


Locations
United Kingdom
Brighton and Sussex University Hospitals NHS Trust
Brighton, United Kingdom
Central and North West London NHS Foundation Trust
London, United Kingdom
Chelsea and Westminster NHS Foundation Trust
London, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
Royal Free Hospital NHS Foundation Trust
London, United Kingdom
Sponsors and Collaborators
Imperial College London
Medical Research Council
University of Oxford
University of Cambridge
Chelsea and Westminster NHS Foundation Trust
Royal Free Hospital NHS Foundation Trust
Brighton and Sussex University Hospitals NHS Trust
Guy's and St Thomas' NHS Foundation Trust
Central and North West London NHS Foundation Trust
Investigators
Principal Investigator: Sarah Fidler, MD Imperial College London
  More Information

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02336074     History of Changes
Other Study ID Numbers: CCT-NAPN-24772
2014-001425-32 ( EudraCT Number )
First Submitted: October 23, 2014
First Posted: January 12, 2015
Last Update Posted: March 15, 2017
Last Verified: March 2017

Keywords provided by Imperial College London:
HIV
Vaccine
Cure
Early Intervention
Infection
Primary infection
Reservoir
Vorinostat
HDAC

Additional relevant MeSH terms:
Vaccines
Raltegravir Potassium
Vorinostat
Immunologic Factors
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Histone Deacetylase Inhibitors


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